Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin

Product NDC
85929-100
11-digit product format
859290100
Labeler code
85929
Product ID
85929-100_42467407-870a-ca85-e063-6294a90ad86b
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SPRAY
Route
TOPICAL
Labeler
GAINXTRA LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-07
Substance
MINOXIDIL
Active strength
50 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5965120SH1MINOXIDIL38304-91-5MINOXIDIL

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85929-100-01859290100011 BOTTLE, SPRAY in 1 BOX (85929-100-01) / 60 mL in 1 BOTTLE, SPRAY2025-11-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MinoxidilGAINXTRA LLC2025-10-29HUMAN OTC DRUG LABEL1